CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 317 enrolled
Drug / intervention
Continuous Positive Airway Pressureother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02576587
NCT02576587N/ACompleted

Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation

The Cleveland Clinic·interventional·Posted Oct 15, 2015·Updated Aug 15, 2018

In Brief

A clinical study evaluating Continuous Positive Airway Pressure for Sleep Apnea and Atrial Fibrillation. Completed, enrolled 317 participants across 1 site.

Detailed Summary

The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study. The study involves a case control design to investigate the extent to which there is an independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and controls as those without AF. In order to rigorously address important biologic confounding influences, the cases and controls will be individually matched based upon age, gender, race, and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index, AHI\>=15) will be asked to return for a follow up exam after 3 months of SDB treatment in the Clinical Research Unit (CRU) for collection of the same measures collected at the baseline exam to observe for any significant changes with the purpose of collecting effect size data to inform future clinical trials. The total duration of the study is 4 years. The duration for any individual participant is up to from one to 13 weeks months, including a 3-month treatment period for those with moderate to severe SDB, i.e. AHI\>15.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 15, 2015
Enrollment StartJan 1, 2012
Primary CompletionFeb 22, 2017
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 10.7 years ago

Interventions

Continuous Positive Airway Pressureother

For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.